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Warning Letter to Kabe Follows Recent Safety Alert

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After issuing a safety alert in April, FDA follows up with a Warning Letter to Kabe Labortechnik, the German manufacturer of the R...

Congress Should End Government Layoffs: Professor

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Harvard University health policy professor Benjamin Sommers calls on Congress to stand up against cuts in the federal workforce th...

Prothena Scraps Birtamimab After Phase 3 Miss

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Prothena discontinues the development of birtamimab, its investigational treatment for AL amyloidosis, after the drug failed to me...

Covid Vaccine Nixed for Children/Pregnant Women

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HHS removes Covid-19 vaccine recommendations for healthy children and healthy pregnant women from CDCs recommended immunization sc...

Gene Therapy Trial on Hold After Death

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FDA places a clinical hold on a Rocket Pharmaceuticals Phase 2 pivotal trial for RP-A501, an investigational gene therapy for Dano...

FDA Clears Olympus Endoscope Series

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FDA gives 510(k) clearance to the latest Olympus endoscopes that feature new extended depth of field technology.

Savara Gets Refusal-to-File Letter for Molbreevi BLA

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FDA issues Savara a Refusal-to-File (RTF) letter for its BLA for Molbreevi (molgramostim) inhalation solution for treating autoimm...

Susvimo Approved for Diabetic Retinopathy

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FDA approves Roches Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy.

FDA Backs Covid JN.1-Lineage for Next Boosters

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FDA advises Covid-19 vaccine makers to formulate their products to match the currently circulating JN.1-lineage and preferentially...

Promising Trodelvy Data in Breast Cancer: Gilead

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Gilead Sciences reports promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in pat...